临床检验项目如何进入市场
Sources
This article was written by Cathy Tokarski with additional contributions from:
Fred Lasky, PhD, Director of Diagnostics Compliance for Ortho-Clinical Diagnostics, a division of Johnson & Johnson, Rochester, NY
Robert Murray, PhD, Technical Director for Midwest Diagnostic Pathology at Lutheran General Hospital, Park Ridge, IL
Sue Evans, Vice President of Product Development for Caliper Technologies Corporation
Steven Gutman, MD, Director - Division of Clinical Laboratory Devices, US Food and Drug Administration
David Sundwall, President of the American Clinical Laboratory Association
Elissa Passiment, Executive Director of the American Society for Clinical Laboratory Science
--------
US Food and Drug Administration: Premarket Approval Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses
US Food and Drug Administration: Device Advice, Class I/II Exemptions
